NCT06443749

Brief Summary

Laparoscopic appendectomy is a well-defined surgical technique. However, concerns remain about whether closure of the appendiceal stump should be done with clips, endoloops, staples, or other techniques. If tying is to be used in the closure of the appendiceal stump, there is no consensus on which technique (intracorporoyal, extracorporoyal, etc.) should be used for ligation. For this reason, there is a need for studies on different binding techniques and instruments currently used. The aim of this study was to compare the use of unilateral intracorporeal knot and polymer endoclip closure during laparoscopic appendectomy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 5, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

December 11, 2023

Last Update Submit

May 29, 2024

Conditions

Appendectomy

Keywords

Appendectomy

Outcome Measures

Primary Outcomes (1)

  • operation time

    operation time

    3 months

Study Arms (2)

group1

ACTIVE COMPARATOR

the appendiceal stump will be closed with a polyper homologous clip

Procedure: appendectomy

group

ACTIVE COMPARATOR

the stump will be closed with an intracorporial node with a single instrument in

Procedure: appendectomy

Interventions

appendectomyPROCEDURE

the appendiceal stump will be closed with a polyper homologous clip or with an intracorporial node

groupgroup1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are diagnosed with acute appendicitis

You may not qualify if:

  • bleeding diathesis
  • cirrhotic acid,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Appendectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Sezgin Topuz

CONTACT

+905370252264sezgintpz@gmail.com

Muhammed Alkan

CONTACT

muhammedalkan_@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 11, 2023

First Posted

June 5, 2024

Study Start

August 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

June 5, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share